SUPPLY CHAIN ARTICLES
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![biotechnology, Global Networking, Research, Development, Innovation, Advancing Smart Solutions-GettyImages-2123154659]( "Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control")
Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle ControlOligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
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![mirror, your true self-GettyImages-1264700812]( "\"Mirror, Mirror…\": Reflections On Reducing mRNA Production COGS")
"Mirror, Mirror…": Reflections On Reducing mRNA Production COGSHere, I outline three overarching words of wisdom I gleaned from Life Edit Therapeutics’ April Sena; Tune Therapeutics’ Tyler Goodwin; and University of Sheffield’s Adi on how the mRNA/RNA industry can better control production costs — particularly as it relates to raw material sourcing and usage.
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![Talimogene laherparepvec vaccine-GettyImages-960686030]( "Addressing Challenges In Serialization For Complex Therapeutics")
Addressing Challenges In Serialization For Complex TherapeuticsThe magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
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![Utility teamwork-GettyImages-2211320040]( "From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy")
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA PolicyIn this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact.
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![Cell transfection with plasmid GettyImages-1290924802]( "Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why")
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's WhyThe demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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![iStock-997784670-selection-chain]( "Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault")
Biomanufacturing Capacity Crunch: It's The Supply Chain's FaultWhat's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.
SUPPLY CHAIN VIDEOS
Looking to enhance performance and manufacturing from your DNA backbone without the regulatory concerns? Gain advantages over legacy plasmid DNA backbones and minicircles.
With benefits across applications, nanoplasmids are designed to replace antiquated bacterial backbones, while eliminating antibiotic markers that can cause regulatory concerns.
In response to an audience poll question gauging which cGMP materials have proven the most difficult to source, our speakers provide additional clarity around which IVT & LNP-related materials today are more “commoditized”.
In this opening Advancing RNA Live clip, panelists Max De Long, April Sena, and Venkat Krishnamurthy share the biggest scientific and manufacturing breakthrough made in the world of gRNA production over the past year.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Scientists laboratory pipette GettyImages-621351044]( "Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs")
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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![Integrating Genetic Medicine Into Clinical Care]( "Optimization Of Transient Transfection Of MSCs With Plasmid DNA Or mRNA")
Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.
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![DNA strands, genetic biotechnology, gene cell-GettyImages-2154784301]( "Reduce Contamination Risks When Storing Synthetic DNA")
An alternative to traditional polyethylene bags is offering cell and gene therapy manufacturers a solution to contamination concerns regarding DNA or RNA fragments.
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![GettyImages-1409734937 RNA polymerase]( "RNA Polymerases For Efficient mRNA Manufacturing")
Precise enzyme selection in IVT reduces dsRNA byproducts and boosts capping efficiency. This ensures high-quality mRNA production while easing the burden of complex downstream purification processes.
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![Outsourcing Business Human Resources--GettyImages-1305829382]( "Enabling CDMOs To Focus On Core Priorities")
Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.
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![GettyImages- 1180547354 trial data]( "Understanding CRISPR Clinical Trials: Your Questions Answered")
CRISPR technology is revolutionizing cell and gene therapies, but how do CRISPR clinical trials work? Follow this explanation of CRISPR therapies from the discovery phase to FDA approval.
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![GettyImages-1459917555-lab-research-development-gene-genetic]( "Mastering mRNA Manufacturing: A Focus on Raw Materials & Supply Assurance")
Rapid advancements in mRNA-based therapeutic development have underscored the role of raw material quality and supply chain management in ensuring their successful production.
